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Lancet Lecture Flashcards > Q/A and Q/C Definitions > Flashcards

Q/A and Q/C Definitions Flashcards

1
Q

Calibrator

A

AKA standard. Has a known value. Used to set a machine to specific set points, or in the case of a manual method, a standard has a known value and is used to calculate the patient and control result.

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2
Q

Control

A

Used to make sure that patient results are correct and to validate patient results.

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3
Q

Quantitative test

A

Will have a range that the result should fall within. The range is well established by a proven reference method. NUMERIC
Assayed: reference range is included in the package insert
Unassayed: do not have a predetermined reference range and it needs to be established in the lab.

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4
Q

Qualitative

A

May have a negative or positive control

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5
Q

Shelf Life

A

The time an unopened product is still stable and considered reliable

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6
Q

Accuracy

A

The closeness of the result to the true value (mean)

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7
Q

Precision

A

The ability to get reproducible results

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8
Q

Analyte

A

A constituent of the sample to be measured

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9
Q

Assay

A

To analyse a sample to determine the amount, activity, or potency of an analyte or substance

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10
Q

Mean

A

The average of all values added up and divided by the number of values

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11
Q

Range

A

The difference between the smallest and largest value

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12
Q

Median

A

The middle of a sorted list of numbers

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13
Q

Lyphilised

A

Freeze dried (liquid removed)

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14
Q

Bias

A

The difference between the true value and the value obtained

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15
Q

Shiift

A

A sudden change in control mean which could mean incorrect patient results

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16
Q

Trend

A

A gradual increase or decrease in control values

17
Q

Systematic Error

A

A trend or shift away from the mean

18
Q

Random Error

A

An occasional result that falls outside the range

19
Q

Standard Deviation

A

How close the values are in relation to each other, expresses the average deviation from the mean

20
Q

Coefficient of Variation

A

The standard deviation expressed as a percentage

21
Q

Westgard Rules

A

Rules (6 main) used individually or in combination to evaluate quality of the analytical run

22
Q

Troubleshooting

A

All the steps taken to correct a QC problem or find the cause and solution

23
Q

Carryover

A

When the end products or substances from one test is transferred to the next test

24
Q

Beer’s Law

A

The amount of light of a particular wavelength absorbed by a substance across a constant distance

25
Q

Sensitivity

A

The lowest concentration that can be accurately measured by an assay (lower detection limit)

26
Q

Specificity

A

How good the assay is at discriminating between the analyte and interfering substances

27
Q

Delta Check

A

Comparison of current results on a patient to the previous results

28
Q

SDI

A

A measurement of bias

29
Q

Verification

A

A process with the aim of establishing the operational limits and performance characteristics of a new method

30
Q

Validation

A

The process of checking if the method performs to the claimed specifications in a laboratory

31
Q

Correlation Coefficient

A

Shows the relationship between the 2 methods

32
Q

QA

A

Policies and procedures that are put in place to ensure accurate results and high standard of customer service is maintained

33
Q

Retention Times

A

The length that laboratory related things are kept in the lab

34
Q

Physiological variation of results

A

Differences, fluctuation, or changes of factors

35
Q

Root cause

A

The fundamental reason for the occurence of a problem

36
Q

Corrective Action

A

Identification and documentation of the root cause of the problem.
Investigating thoroughly to ensure no similar problems could occur
Action taken according to the severity of the problem

37
Q

Preventative Action

A

Taking pro-active steps to ensure a potential problem does not occur

38
Q

Risk Analysis

A

Identify possible risk areas of processes and procedures that could lead to failure

Lancet Lecture Flashcards (1 decks)

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